Bioprocess Specialist

Hyde Engineering + ConsultingToronto, Ontario

30+ days ago

Salary

CAD100000–CAD130000 yearly

Job description

The Process Engineer would support the design phase (conceptual, basis of design, detailed design) of a new production facility. This includes supporting FAT’s off-site, construction, SAT’s, commissioning, and field engineering for the final phases of the project.

Responsibilities

Support / lead the design and specification of cGMP equipment, processes and utilities for biopharma projects.
Create and review project documentation (URS, FRS, Technical Specifications, Functional Specifications)
Create and review process models and sizing calculations for process equipment, control valves etc
Manage and populate equipment / line / valve / instrument lists and equipment data sheets
Liaise with client end user groups to ensure correct specification of equipment and utilities
Create Technical Specification and Functional Specification for automated and manual equipment
Specify requirements for tanks, valves, pumps, fermenters, centrifuges, UF / DF systems, chromatography columns
Sizing and specification of utility systems (clean and plant); RODI, PW, WFI, Clean Steam, Plant Steam, Clean Compressed Air, Other Process Gases, & Waste Systems.
Provide engineering expertise and drive technical decisions as active member

Desired Skills and Experience

BS degree or higher in chemical or mechanical engineering

5-8 experience in the Biopharmaceutical industry, preferably in a consulting capacity

Must have demonstrated engineering project management experience ideally in a construction environment

Familiarity with process design and operations (block flow diagrams, process flow diagrams, etc…)

Experience with downstream processing experience (TFF, microfiltration, ultrafiltration, centrifuge, depth filters, harvest, purification)

Experience with Fill / Finish

Experience with startup, walkdowns, as-built P&IDs, FAT, SAT and commissioning

Experience with clean utilities and drop points, connections, drain and waste systems

Excellent knowledge of ASME BPE, ISPE and FDA cGMP requirements

Strong verbal and written communication skills

Ability to work independently and within project teams.

Industry experience related to cGMP drug manufacturing, validation, and chemical process design

Strong computer knowledge including Microsoft Office products

Are you looking for a meaningful career that makes a difference in the world? Consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. To read more about Hyde's culture and benefits, visit our website : www.hyde-ec.com

Hyde is an equal opportunity, affirmative action employer.

LI-JS1

LI-Hybrid

Associate